Key characteristics of gastrointestinal surgery studies (n=29)
| First author's name | Year | Country | Primary or Secondary aim | Sample (N=number of patients in analysis/eligible patients, Nt(i)=sample size per time point, Nc=patients with complications, N1=cases vs N2=controls) | Patient inclusion criteria | Study design | Type of surgery | Surgical complications/method of recording | Psychosocial outcome/time points/measurement tool | Significant association of surgical complications with patients’ well-being (yes/no/confounding) | Types of complications and time points of significant effects | Quality assessment score (out of 8) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anthony | 2003 | US | Secondary | Nt1=71/? Nt2=63 Nc=16 | Colorectal cancer, male patients who underwent open surgical therapy | Observational, cohort, prospective | Open surgical therapy for colorectal cancer | Morbidity was defined as any event that resulted in the need for additional therapy or readmission to the hospital within 30 days of initial discharge/method not specified | QoL/at time of diagnosis and 12 months after surgery/FACT-C | Yes* | Any complications/12 months postsurgery | 6 |
| Avery | 2006 | UK | Primary | N=139/162 Nc=37 | Patients with oesophageal or gastric cancer who underwent upper gastrointestinal surgical treatment | Observational, cross-sectional | Upper gastrointestinal surgical treatment for oesophageal or gastric cancer | A major complication was defined as reoperation, readmission to the high dependency or intensive care unit, readmission to the hospital within 30 days of operation, or death within 30 days of operation or later if the patient did not leave the hospital/method not specified | QOL/39.6 days after treatment (range 6–105)/EORTC QLQ-C30 | Yes | Any complications/39.6 days after treatment (range 6–105) | 5 |
| Bitzer | 2008 | Germany | Secondary | Nt1=151/205 Nt2=130 (86.1%) Nc(complaints)=49 Nc(wound infection)=5 Nc(seroma)=13 Nc(pneumonia)=1 Nc(other)=28 | Patients undergoing cholecystectomy | Observational, cohort, prospective | Cholecystectomy | Retrospective list: any complaint, wound infection, seroma, pneumonia, other complaints/patient reports | QoL/14 days preoperative, 14 days postoperative, and 6 months postoperative/SF-36 | Yes* | Any complications/6 months postsurgery | 7 |
| Bloemen | 2009 | The Netherlands | Primary | N=121/170 Nc=33 | Patients with rectal cancer | Observational, cross-sectional | Surgical treatment for adenocarcinoma of the rectum | Only severe complications were considered: grade III or IV complications (according to Dindo's model) were defined as severe, whereas absence of complications or grade I and II complications were defined as absent or mild complications/patient records | QoL/36 (16–51) months postoperative/EORTC QLQ-C30 and CR38 | Yes | Severe postoperative complications/median of 36 (range 16–51) months postsurgery | 6 |
| Bruns | 2010 | Germany | Secondary | N=96/188 Nc(any morbidity)=30 Nc(wound infections)=10 | Patients who underwent curative hepatic resection for malignant or non-malignant diseases, disease free at time of assessment | Observational, cross-sectional | Hepatectomy | Surgical (eg, bile leak or biloma, pneumothorax, wound infection, liver abscess, bleeding, and surgical dehiscence) and medical (eg, pleural effusion, renal failure, hepatic failure, pneumonia, cardiac insufficiency and cholangitis)/patient records | QoL/ 3–36 months postoperative /SF-12 | Yes | Wound infections/3–36 months postsurgery | 5 |
| Champault | 2006 | France | Secondary | Nt1=152/? Nt(4)=139 Nc=(unclear) | Consecutive patients operated on for morbid obesity | Observational, cohort, prospective | Laparoscopic placement of a gastric band | Retrospective list: pulmonary atelectasis or pneumonia, prolonged ileus, minor wounds problems and urinary retention. Slippage with a peak incidence during the second postoperative year. Band erosion with penetration into the stomach. Access port problems (infection, haematoma, leak, disconnection), bands explanted, associated with erosion, obstruction, immediate intolerance and recurrent tubing break/method not specified | QoL/preoperative, 1, 3 months and 2 years postoperative/GIQLI | Confounding* | Band removal for complications such as erosion, slippage, intolerance/2-year postsurgery | 6 |
| Chang | 2010 | Taiwan | Secondary | N=102/218 Nc(anastomotic stricture)=12 Nc(gastrojejunal anastomotic ulcer)=9 Nc(upper gastrointestinal bleeding)=1 N(GORD)=2 | Patients undergoing bariatric surgery. | Observational, case–control, longitudinal | Roux-en-Y bypass | Operation-related complications, including gastrojejunal anastomotic stricture, gastrojejunal anastomotic ulcer, upper gastrointestinal bleeding and Gastro-oesophageal reflux disease (GORD)/method not specified | QoL/preoperative, 1, 3, 6 and 12 months postoperative/WHOQoL-BREF | Yes* | Any complications/1, 3, 6, 12 months postsurgery | 5 |
| Dasgupta | 2008 | UK | Secondary | Nt1=102/122 Nt2=87 Nt3=80 Nt4=33 Nc=44 | Consecutive, patients undergoing liver surgery for liver cancer | Observational, prospective, cohort | Liver resection for hepatic malignancies | Major complications were defined as those associated with systemic illness requiring transfer to a higher level of care (high dependency or intensive care unit) or requiring relaparotomy, or complications needing interventional radiology/method not specified | QoL/preoperative, 6, 12, 36–48 months postoperative/EORTC QLQ-C30 | No* | NA | 6 |
| Delaney | 2003 | USA | Secondary | Nt1=109/109 Nt2=82/109 Nc(any)=19 Nc(major)=9 | Patients with Crohn's disease | Observational, cohort, prospective | Surgery for CD (abdominal perineal, loop or end stoma) | Retrospectively listed complications: anastomotic leak, intra-abdominal abscess, bleeding, venous thrombosis, renal failure, and pneumonia, dehydration, intra-abdominal abscess, small bowel obstruction and wound infection/database review | QoL/preoperative and 30 days postoperative/CGQL | Yes* | Any complications/30 days postoperative | 7 |
| Douma | 2011 | The Netherlands | Secondary | N=296/? Nc=? | 296 patients with FAP who had been surgically treated | Observational, cross-sectional | Surgery for FAP | Surgery-related complications/self-reports+medical records | QoL/0 to >10 years postoperative/SF-36, EORTC-QLQ-C38,Social Functioning subscale of the Dutch version of IBDQ | Yes | Any complications/0 to >10 years postsurgery | 2 |
| Dubernard | 2006 | France | Secondary | Nt1=58/? Nt2=58 Nc=9 | Women with colorectal endometriosis who underwent a segmental colorectal resection | Observational, cohort, prospective | Laparoscopic segmental colorectal resection for endometriosis | Retrospectively listed complications: rectovaginal fistulae, vessel injury of the protective colostomy treated by laparoscopic coagulation, uroperitoneum requiring a ureteral stent for 6 weeks and an abscess behind colorectal anastomosis requiring a laparoscopic drainage/patient observations | QoL/preoperative and postoperative/SF-36 | No* | NA | 6 |
| El-Awady | 2009 | Egypt | Secondary | N=40/? Nc=14 | Patients with inguinal hernia | Observational, prospective, cohort | Anterior open Lichtenstein tension-free hernioplasty | Postoperative complications: seroma, haematoma, secondary infection, neuralgia and anaesthesia/patient observations | QoL/preoperative, 3, 6 and 12 months postoperative/SF-36 | No | NA | 4 |
| Hawn | 2006 | USA | Primary | Nt1=1983/3518 Nt2=1526 (77%) Nt3=1603 (81%) Nc(neuralgia t1)=94 Nc(haematoma t1)=51 Nc(orchitis t1)=13 Nc(recurrence t1)=76 Nc(other t1)=124 Nc(neuralgia t2)=105 Nc(haematoma t2)=55 Nc(orchitis t2)=18 Nc(other t2)=150 | Men who received a hernia repair | Observational, cohort, prospective | Inguinal herniorrhaphy | Complications were summarised by 4 categories: (1) haematoma/seroma, (2) orchitis, (3) neuralgia of the leg or groin, and (4) other. complications classified as ‘other’ included (1) early postoperative complications (urinary tract infection, urinary retention, and haematuria); (2) life-threatening complications (respiratory insufficiency, myocardial ischaemia, cardiac arrhythmia, intraoperative hypotension and stroke); and (3) long-term complications (4 weeks or more postoperative)/patient reports for neuralgia and orchitis + expert consensus for life-threatening complications | QOL/pre-op, 1 &2 years post-op/SF-36 | Yes* | Neuralgia, orchitis/2 years postsurgery | 8 |
| Ince | 2011 | USA | Secondary | Nt1=?/568 Nt2=166 Nc=? | Patients who underwent colorectal resection for benign and malignant diseases. | Observational, cohort, retrospective | Laparoscopic colorectal resection | No reference | QOL/pre-op, 4 weeks post-op/SF-36 | No* | NA | 3 |
| Kalliomaki | 2009 | Sweden | Primary | N(total)=184/423 N1=92 (cases) N2=92 (controls) | Patients who had been operated on for groin hernia. Controls matched for age, gender and method of surgical repair were allotted from the group of persons without persisting pain (grade 1 in IPQ) | Observational, case–control, cross-sectional | Hernia repair | Persistent postoperative pain (patients with pain of grade 3, ie, pain that could not be ignored but did not interfere with everyday activities, or higher on IPQ)/patient reports (IPQ) and clinical examination | QoL, anxiety, depression/(on average 4.9 years postoperative, range > 7 years)/SF-36, HADS | Yes | Persistent postoperative/mean of 4.9 years postsurgery | 5 |
| Kement | 2011 | Turkey | Primary | N=253/351 N(incontinence)=28 N(severe incontinence)=9 N(mild incontinence)=19 | Consecutive patients with chronic anal fissure who underwent open lateral internal sphincterotomy (LIS). | Observational, cross-sectional | Open lateral internal sphincterotomy | Anal incontinence/patient reports: WIS system + clinical examination | QoL/23.3±7.1 months postoperative/SF-36 | Yes | Severe incontinence/23.3 (SD±7.1) months postsurgery | 5 |
| Lim | 2006 | UK | Primary | N=92/112 Nc(leaks)=23 Nc(clinical leaks)=13 Nc(subclinical leaks)=10 | Consecutive patients under the care of three consultant surgeons who underwent procedures with LRA | Observational, cross-sectional | LRA | Anastomotic leaks (clinical and subclinical)/patient observations, CT scans, Wireless Capsule Endoscopy (WCE) | QoL/10–18 months postoperative/EORTC QoL | Confounding | Anastomotic leaks/10–18 months postoperative | 5 |
| Liu | 2010 | US | Primary | N=679/1308 Nc(early comps/anastomosis)=54 Nc(late comps/anastomosis)=126 Nc(early comps/anastomosis/rectal cancer only)=42 Nc(late comps/ostomy/rectal cancer only)=105 | Patients with long-term colorectal cancer | Observational, cross-sectional | Colorectal cancer surgery | Digestive, skin, genitourinary, surgical, medical, immediate indirect complicationsEarly complications: those that were first recorded within 30 days of the surgery. Late complications: occurring 31 days after surgery/patient computerised data | QoL/ 5–15 years postoperative/modified City of Hope (mCOH)-QoL-Ostomy | Yes | Enterocutaneous fistula for all patients and any late complications for ostomy patients >5 years postsurgery | 6 |
| Mentes | 2006 | Turkey | Primary | Nt1=253/302 Nt2=244 Nc(anal fistula/abscess)=3 Nc(Fecal Incontinence Severity Index (FISI)>0)=7 Nc(FISI, 0 to >4, 21, 7)=3 | Patients who underwent lateral internal sphincterotomy (LIS) for CAF | Observational, cohort, prospective | Lateral internal sphincterotomy (LIS) for CAF | Anal incontinence/atient examination+ FISI score | QoL/preoperative (admission) and 12 months postoperative/GIQLI and FIQL | Unclear (due to small number of patients with complications) | NA | 6 |
| Pittman | 2008 | USA | Primary | N=239/322 Nc=56 | Veterans with an ostomy after major gastrointestinal surgery requiring an intestinal stoma | Observational, case–control, cross-sectional | Gastrointestinal surgery requiring an intestinal stoma | Ostomy complications: skin problems, leakage and difficulty with adjustment (ie, leakage, peristomal irritant dermitis, pain, bleeding, stomal necrosis, prolapse, stenosis, herniation, retraction, infection, mucotaneous separation, difficulty adjusting)/patient reports | QoL/6 months postoperative/mCOH-QoL-Ostomy | Yes | Ostomy complications (skin problems, leakage)/ 6 months postsurgery | 6 |
| Polese | 2012 | Italy | Primary | N=147/211 Nc(anastomotic stenoses)=22 | Patients who underwent elective left colonic or rectal resection and colorectal anastomosis for neoplastic or inflammatory disease | Observational, cross-sectional | Left colonic or rectal resection and colorectal anastomosis | Anastomotic stenosis/clinical examination | QoL/mean 58 (SD±31) months postoperative/SF-36 | Yes | Anastomotic stenosis/58 (SD±31) months postsurgery | 6 |
| Rea | 2007 | USA | Primary | Nt1=505/? Nt2=237 Nt3=106 Nc(t2)=41 Nc(t3)=23 | Patients who underwent Roux-en-Y gastric bypass (LRYGB) by one surgeon for morbid obesity | Observational, cohort, prospective | LRYGB for morbid obesity without conversion to an open procedure | Postoperative complications requiring intervention/method not specified | QoL/baseline, 1 and 2 years postoperative/SF-36 | Yes* | Complications requiring intervention/1 and 2 years postsurgery | 6 |
| Riss | 2011 | Austria | Primary | N1=16/36 (cases) N2=16/? (controls) | Cases: patients operated for rectal cancer and developed anastomotic leak. Controls: patients operated for rectal cancer at the same time period and had an uneventful postoperative course matched by sex, age (±5 years), type of resection, and neoadjuvant therapy | Observational, case–control, cross-sectional | Rectal resection for malignancies on overall pelvic organ function | Anastomotic leakage: defined as grade A (no change in patient's management), grade B (requires active therapeutic intervention but is managed without relaparotomy) and grade C (requires relaparotomy)/review of the institutional colorectal database and individual chart reviews | QoL/106.8 months postoperative (32.4–170.4)/SF-12 | No | NA | 7 |
| Rutegard | 2008 | Sweden | Secondary | N=355/446 (79·6%) Nc=56 | Patients diagnosed with an oesophageal or cardia cancer who underwent macroscopically and microscopically radical resection | Observational, cross-sectional | Oesophageal resection | Technical surgical complications, including postoperative bleed exceeding 2000 ml or requiring a reoperation, anastomotic insufficiency, necrosis of the substitute, damage to the recurrent nerve, thoracic duct damage or gastric perforation/prospective scrutiny of medical and histopathological records, operation charts, extensive study protocol with predefined exposure alternatives | QoL/6 months postoperative/EORT QLQ-C30, and QLQ-OES1812 | Yes | Technical complications/6 months postsurgery | 7 |
| Scarpa | 2009 | Italy | Secondary | N=47/? Nc=? | Patients admitted for intestinal surgery for Crohn's disease | Observational, cross-sectional | Bowel resection through midline laparotomy or with laparoscopic assistance, end ileostomy, stricturoplasty | Medical and surgical complications and need of reoperation (2 anastomotic leaks, 3 intestinal obstructions, 2 intestinal bleeding, and a wound infection were recorded and two relaparotomies)/method not specified | QoL/3 months postoperative/CGQLI | Confounding | Any complications/3 months postsurgery | 3 |
| Sharma | 2007 | UK | Secondary | Nt1=104/110 Nt2=92 Nc=41 | Consecutive patients with newly diagnosed colorectal cancer scheduled for elective open resection in one hospital trust | Observational, cohort, prospective | Elective resection for colorectal cancer | Wound, urinary tract and chest infections, cardiac and respiratory complications, deep venous thrombosis, pulmonary embolism and complications related to anastomotic breakdown/method not specified | QoL, anxiety, depression, positive vs negative affectivity, mood states/preoperative (5–12 days preoperative) and 6–8 weeks postoperative/FACT-C, EuroQOL (EQ-5D), HADS, PANAS, MRS | Yes* | Complications within 30 days of operation/6–8 weeks postsurgery | 6 |
| Siassi | 2009 | Germany | Secondary | Nt1=93/113 Nt2,t3=79 Nc=26 | Patients undergoing colorectal surgery for benign and malignant disease | Observational, prospective, cohort | Resection of the sigmoid colon or rectum | Postoperative complications (anastomotic leak, wound infection, delayed food intake, fever, and bladder dysfunction)/method not specified | QoL/preoperative, 3 and 12 months postoperative/SF-36 and GLQI | Yes* | Any complications/3 months postsurgery | 7 |
| Targarona | 2004 | Spain | Primary | N=37/46 Nc(recurrent hernias)=3 | Patients diagnosed with paraoesophageal or mixed hiatal hernia (types II, III and IV) with >50% of the stomach in the chest | Observational, cross-sectional | Laparoscopic repair of paraoesophageal hiatal hernia | Hernia recurrence (any migration of the cardia to chest level or evidence of a new paraoesophageal sac)/a barium swallow was given to all patients to rule out an anatomic recurrence. An independent radiologist evaluated all the explorations | QoL/≥6 months postoperative (median, 24; range, 6–50)/SF-36, GDSS and GIQLI | Yes | Clinically recurrent hernias/≥6 months postsurgery | 5 |
| Viklund | 2005 | Sweden | Secondary | N=100/146 Nc=44 | Patients newly diagnosed with a histologically verified adenocarcinoma or squamous-cell carcinoma of the oesophagus or adenocarcinoma of the gastric cardia that underwent macroscopically and microscopically radical tumour resection | Observational, cross-sectional | Oesophageal resection surgery for cancer | Anastomotic leakage, infections, respiratory insufficiency, cardiac complications, technical complications, anastomotic strictures, and others (intervention needed to treat embolus, deep venous thrombosis, rupture of the wound, intestinal obstruction, stroke, renal failure, or liver failure)/patient records | QoL/6 months postdischarge/QLQ-C30 and OES-24 | Yes | Any complications, anastomotic leakage, infection, respiratory insufficiency, cardiac complications, technical complications/6 months postdischarge | 7 |
Symptoms specific to oesophageal cancer.
*Study controlled for patients’ preoperative well-being.
CAF, chronic anal fissure; CGQL, Cleveland Global Quality of Life; COH-QoL Ostomy, City of Hope Quality of Life for Ostomates questionnaire; EORTC, European Organisation for Research and Treatment of Cancer core; EORTC, European Organisation for Research and Treatment of colorectal cancer; FACT-C, Functional Assessment of Cancer Therapy questionnaire with the colorectal module; FAP, familial adenomatous polyposis; FIQL, Fecal Incontinence Quality of Life Instrument; GDSS, Glasgow Dyspepsia Severity Score; GIQLI, Gastrointestinal Quality of Life Index; GLQI, Gastrointestinal Quality of Life Index; HADS, Hospital Anxiety and Depression Scale; IBDQ, Inflammatory Bowel Disease Questionnaire; IPQ, Inguinal Pain Questionnaire; LRA, low rectal anastomosis; MRS, Mood Rating Scale; NA, not available; OES, Oesophageal Cancer-Specific questionnaire; PANAS, positive and negative affect schedule; SF, Short Form Health Survey; WHOQoL BREF, WHO Quality of Life—Brief; WIS, Wexner Incontinence Score.