Bowel obstruction after laparoscopic and open colon resection for cancer: results of 5 years of follow-up in a randomized trial.

BACKGROUND: Postoperative bowel obstruction caused by intra-abdominal adhesions occurs after all types of abdominal surgery. It has been suggested that the laparoscopic technique should reduce the risk for adhesion formation and thus for postoperative bowel obstruction. This study was designed to compare the incidence of bowel obstruction in a randomized trial where laparoscopic and open resection for colon cancer was compared. METHODS: A retrospective analysis was performed, collecting data of episodes of bowel obstruction with or without surgery. Only episodes treated in the hospital where the index surgery took place were included. Data for 786 patients were collected for the 5-year period after cancer surgery. RESULTS: Baseline characteristics for the evaluated laparoscopic (n = 383) and open (n = 403) groups were comparable. The cumulative obstruction percentages at 5 years for the open and laparoscopic groups were 6.5 and 5.1% respectively and did not significantly differ from each other. Tumor stage seemed to influence the risk for bowel obstruction: 2.8% in stage I, 6.6% in stage II, and 7% in stage III, but the differences were not significant. CONCLUSIONS: This analysis does not support the hypothesis that laparoscopy leads to fewer episodes of bowel obstruction compared with open surgery.

LAPPRO: a prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer.

OBJECTIVE: This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. MATERIAL AND METHODS: The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. RESULTS: The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. CONCLUSIONS: The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.

Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial.

OBJECTIVE: The colon cancer laparoscopic or open resection (COLOR) trial is an international, randomised controlled trial comparing outcomes of open and laparoscopic surgery for colon cancer. The main purpose of this study was to determine representability by comparing included and nonincluded patients in the participating Swedish centres. DESIGN: At eight centres, which included 391 of the 422 Swedish patients, a local database search was performed to identify retrospectively all patients (n = 2,384) who underwent surgery for colon cancer during the inclusion period, and data was retrieved from medical records. RESULTS: Four hundred fifty-six patients were randomised, 65 of whom were excluded post randomisation (group 2), leaving 391 patients in the study (group 1). For 1,566 patients, valid exclusion criteria were found (group 3). Thus, 362 patients were eligible but not included (group 4). Relative to group 1, patients in group 4 had a significantly higher American Society of Anaesthesiologists (ASA) score, more advanced tumour stage and difference regarding the resections performed. Results showed that 1470 patients (62%) could be calculated as feasible for laparoscopic colon resection (LCR) in a clinical, nontrial situation. CONCLUSIONS: The study population in the Swedish part of the COLOR trial was representative of the eligible population with the exception of comorbidity, where those actually included had less severe comorbidity than the nonincluded but eligible patients. In Sweden, 50-60% of colon cancer patients can be operated on by laparoscopy.

Outpatient versus inpatient laparoscopic cholecystectomy: a prospective randomized study of symptom occurrence, symptom distress and general state of health during the first post-operative week.

BACKGROUND: Few randomized clinical trials focus on patients' symptoms of the first post-operative week following outpatient (OPS) versus inpatient (IPS) laparoscopic cholecystectomy (LC). The objective was to compare these treatment modalities with regard to patients' perceptions of pain and other post-operative symptoms, amount of distress, level of anxiety and general state of health during the first post-operative week. METHODS: One hundred patients were randomized. Seventy-three LC patients were valid for efficacy (OPS n=34, IPS n=39). Data were collected by means of questionnaires. RESULTS: The main result was that only minor [corrected] differences were seen between the groups regarding the occurrence of post-operative symptoms or symptom distress. Approximately 90% of the patients in both groups perceived pain, reduced mobility and tiredness on day 1. Nausea and loss of appetite were reported by half of the patients. Post-operative day 1, both groups reported much or very much distress related to pain and reduced mobility (approximately 40%) and nausea (approximately 20%). Although both groups reported less symptoms on day 7, one-third still experienced pain, but only one patient reported this to be distressing. CONCLUSION: Laparoscopic cholecystectomy patients in both groups recover equally well, indicating that a greater proportion of LC patients should be offered the outpatient modality.

Randomized trial of health-related quality of life after open and laparoscopic surgery for colon cancer.

BACKGROUND: Randomized controlled trials (RCTs) have reported improved or unchanged three-year survival following laparoscopic colon resection (LCR) for colon cancer compared with that following open resection (OCR). The aim of this study was to determine health-related quality of life (HRQL) in patients randomized to laparoscopic or open resection for colon cancer. METHODS: In total, 285 patients (130 LCR, 155 OCR) from seven Swedish centers were included. HRQL was assessed preoperatively and at 2, 4, and 12 weeks postoperatively with the EQ-5D and EORTC QLQ-C30 instruments. RESULTS: The LCR patients did significantly better on the social function component of the EORTC QLQ-C30 at two and four weeks and on the role function component at two weeks. CONCLUSION: Laparoscopic resection for colon cancer improved quality of life during the first postoperative month.

Long-term outcome is worse after laparoscopic than after conventional Nissen fundoplication.

OBJECTIVE: No long-term studies of laparoscopic and open fundoplication were available in 1994. The aim of this study was to compare reflux control and side effects after laparoscopic and open fundoplication. MATERIAL AND METHODS: Adult patients with uncomplicated gastro-oesophageal reflux disease were included in this prospective randomized clinical trial between laparoscopic and open 360-degree fundoplication. Patients with uncomplicated gastro-oesophageal reflux disease were included with the exception of those with weak peristalsis or suspected short oesophagus. Two senior surgeons, well trained in laparoscopic antireflux surgery, performed the 45 laparoscopic operations. Forty-eight patients underwent open surgery performed or supervised by two other senior surgeons, also well trained in gastro-oesophageal surgery. One of the latter recruited all the patients. Manometry and 24-h oesophageal pH monitoring were performed before operation and 6 months postoperatively. Manometry also included a short-term reflux test, an acid clearing test and an acid perfusion test. Symptom evaluation was performed before surgery, 6 months after and at long-term follow-up (33-79 months postoperatively) by the same surgeon. Long-term follow-up also included endoscopy. RESULTS: Six months after laparoscopy 4 patients had disabling dysphagia. None of the patient had disabling dysphagia after laparotomy. Four patients had mild heartburn 6 months after laparoscopy and 2 patients after laparotomy. Between 6 months' follow-up and long-term follow-up, 6 patients were reoperated on in the laparoscopy group and 2 patients in the laparotomy group. Three patients operated on with laparotomy had died of intercurrent diseases. After laparoscopy, at long-term follow-up, 62% of patients (28/45) were satisfied compared with 91% (41/45) after laparotomy. The difference was significant (p<0.01). CONCLUSIONS: Early postoperative reflux control was similar for laparoscopic and conventional fundoplication. At long-term follow-up significantly more patients were satisfied after laparotomy than after laparoscopy.

Data validation in an economic evaluation of surgery for colon cancer.

OBJECTIVES: This study aimed to validate the accuracy of data retrieved in a prospective multicenter trial, the purpose of which was an economic evaluation of two techniques of surgery for colon cancer. METHODS: Within the Swedish contribution of the COLOR trial (Colon Cancer Open or Laparoscopic Resection), an economic evaluation of open versus laparoscopic surgical techniques was conducted. Data were collected by case record forms (CRF), patient diaries, and telephone surveys every 2 weeks. The study period was 12 weeks, and the perspective was societal. Data from the first consecutive forty patients to complete the health economic study protocol were validated. Retrieved data were compared with data from medical records and data from local social security offices for agreement. RESULTS: Statistically significant differences were found for duration of anesthesia, length of surgery, number of outpatient consultations by doctors and district nurses, complication rate, and the use of central venous lines. No significant differences were observed concerning length of hospital stay, disposable instruments cost, and time off work, all of which heavily influence total costs. CONCLUSIONS: The present method of data collection regarding resources used in this setting seems to produce accurate data for economic evaluation; however, relative to complication rates, the method did not retrieve accurate data.

Early results of a single-blinded, randomized, controlled, Internet-based multicenter trial comparing Prolene and Vypro II mesh in Lichtenstein hernioplasty.

BACKGROUND: The standard polypropylene mesh used in Lichtenstein's operation induces a strong foreign-tissue reaction with potentially harmful effects. A mesh with less polypropylene could possibly be beneficial. PATIENTS AND METHODS: Six hundred men with inguinal hernias were randomized to Lichtenstein's operation with Prolene or Vypro II in a single-blinded multicenter trial. The randomization was performed by a computer algorithm in a database through the Internet. All data were entered and directly validated in the database through the Internet. RESULTS: The meshes had comparable results in return to work, return to daily activities, complications, postoperative pain, and quality of life during the first 8 weeks of rehabilitation. CONCLUSIONS: Lichtenstein's operation with either Prolene or Vypro II is safe and well tolerated with an acceptable postoperative rehabilitation time and a high quality of life 2 months after surgery. The study was facilitated by the use of a database through the Internet.

Patients' experiences of laparoscopic cholecystectomy in day surgery.

Previous research has concentrated mainly on surgical aspects and postoperative complication rates after day surgery laparoscopic cholecystectomy (LC), and less on patients' experiences and nursing care aspects. A qualitative study was conducted aimed at investigating patients' experiences of LC in day surgery. Ten women and two men were interviewed. The material was coded, categorized and analysed using qualitative analysis. The findings demonstrate that individuals with gallstone disease experience limitations in their daily life and feelings of socially handicapped. Prior to surgery, the patients felt anxious and expressed a wish for tranquilizers, and to meet the surgeon responsible. At discharge after day surgery, amnesia was experienced and the respondents did not remember important information about the operation given by the surgeon. Experience of postoperative pain varied greatly. Several respondents had a relapse of pain on the third day lasting up to 1 week. The need for additional pain medication and a bloated feeling were reported. Some respondents reported nausea and vomiting, and most had questions about wound care. The need for additional telephone follow-up was mentioned, as was the fact that it was difficult to come home to small children. However, the great majority felt that returning home on the same day as the operation, was positive.

Tension-free inguinal hernia repair: TEP versus mesh-plug versus Lichtenstein: a prospective randomized controlled trial.

OBJECTIVE: To compare laparoscopic hernioplasty with two open tension-free hernia repairs. SUMMARY BACKGROUND DATA: Laparoscopic hernioplasty is associated with a short rehabilitation, but it is a technically difficult procedure. It is unclear if it has advantages over the technically easier open tension-free herniorrhaphy. METHODS: Two hundred ninety-nine men 30 to 75 years old were randomized to undergo laparoscopic totally extraperitoneal hernioplasty (TEP), open operation with mesh-plug and patch, or Lichtenstein's operation. RESULTS: Two hundred ninety-four (98%) patients were followed for 19.8 +/- 8.6 months. Over 90% of the patients in all groups were operated in day surgery; the rest of the patients were all discharged within 24 hours. Postoperative pain (visual analog score) was lower in the patients undergoing TEP than in those undergoing Lichtenstein and mesh-plug procedures. The median sick-leave period was 5 days in the TEP group, 7 days in the mesh-plug group, and 7 days in the Lichtenstein group. The median time to full recovery was significantly shorter in the TEP group compared to the other two groups. There were no major complications. Two recurrences were found in the TEP group and two in the mesh-plug group. CONCLUSIONS: Laparoscopic hernioplasty is superior to tension-free open herniorrhaphy in terms of postoperative pain and rehabilitation.

Prospective evaluation of laparoscopic and open 360 degree fundoplication in mild and severe gastro-oesophageal reflux disease.

OBJECTIVE: To investigate the relationship between five-year control of reflux and early postoperative oesophageal function after total fundoplication done either laparoscopically or through a laparotomy in severe and mild reflux disease. DESIGN: Prospective open study. SETTING: University hospital, Sweden. PATIENTS: In the group with severe disease 9 patients had a laparotomy and 7 laparoscopy. The corresponding figures for the group with mild disease were 21 and 34 respectively. RESULTS: The increase in lower oesophageal sphincter pressure 6 months after operation in patients with recurrent disease was significantly less than that for patients with good reflux control (p < 0.01). In patients who had laparotomy, including 30% (9/30) with severe reflux disease, good long-term reflux control was found in 93% (27/29). In patients operated on laparoscopically including 17% (7/41) with severe reflux disease good long-term reflux control was found in 90% (35/39). CONCLUSION: The mechanism of recurrence differed between patients with severe disease who had a laparotomy and patients with mild disease operated on laparoscopically. Early postoperative manometry was prognostic for recurrence. Long-term reflux control seems to be similar after laparotomy and laparoscopy. Further randomised studies are needed.