Cost-effectiveness and quality of life in surgeon versus general practitioner-organised colon cancer surveillance: a randomised controlled trial.

OBJECTIVE: To assess whether colon cancer follow-up can be organised by general practitioners (GPs) without a decline in the patient's quality of life (QoL) and increase in cost or time to cancer diagnoses, compared to hospital follow-up. DESIGN: Randomised controlled trial. SETTING: Northern Norway Health Authority Trust, 4 trusts, 11 hospitals and 88 local communities. PARTICIPANTS: Patients surgically treated for colon cancer, hospital surgeons and community GPs. INTERVENTION: 24-month follow-up according to national guidelines at the community GP office. To ensure a high follow-up guideline adherence, a decision support tool for patients and GPs were used. MAIN OUTCOME MEASURES: Primary outcomes were QoL, measured by the global health scales of the European Organisation for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ C-30) and EuroQol-5D (EQ-5D). Secondary outcomes were cost-effectiveness and time to cancer diagnoses. RESULTS: 110 patients were randomised to intervention (n=55) or control (n=55), and followed by 78 GPs (942 follow-up months) and 70 surgeons (942 follow-up months), respectively. Compared to baseline, there was a significant improvement in postoperative QoL (p=0.003), but no differences between groups were revealed (mean difference at 1, 3, 6, 9, 12, 15, 18, 21 and 24-month follow-up appointments): Global Health; Δ-2.23, p=0.20; EQ-5D index; Δ-0.10, p=0.48, EQ-5D VAS; Δ-1.1, p=0.44. There were no differences in time to recurrent cancer diagnosis (GP 35 days vs surgeon 45 days, p=0.46); 14 recurrences were detected (GP 6 vs surgeon 8) and 7 metastases surgeries performed (GP 3 vs surgeon 4). The follow-up programme initiated 1186 healthcare contacts (GP 678 vs surgeon 508), 1105 diagnostic tests (GP 592 vs surgeon 513) and 778 hospital travels (GP 250 vs surgeon 528). GP organised follow-up was associated with societal cost savings (£8233 vs £9889, p<0.001). CONCLUSIONS: GP-organised follow-up was associated with no decline in QoL, no increase in time to recurrent cancer diagnosis and cost savings. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00572143.

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

BACKGROUND: All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP) without altering quality of life, cost effectiveness and/or the incidence of serious clinical events. METHODS AND DESIGN: Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group) or follow-up by the district GP (intervention group). Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL) (measured by the EORTC QLQ C-30 and the EQ-5D instruments), serious clinical events (SCEs), and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients. DISCUSSION: There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines) by GPs will not have any impact on patients' quality of life. Furthermore, we hypothesize that there will be no increase in SCEs and that the incremental cost-effectiveness ratio will improve. TRIAL REGISTRATION: This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00572143.

[Complaints before and after cholecystectomy]. / Plager før og etter kolecystektomi.

BACKGROUND: It may be difficult to decide whether a patient's discomfort is related to known gallbladder stones. MATERIAL AND METHODS: A questionnaire regarding pre- and postoperative complaints and satisfaction with treatment was sent to 211 patients a median 51 months after they had undergone cholecystectomy at Rana district hospital during the May 1993 to March 2001 period. RESULTS: 97% of the patients returned our questionnaire. 80% had experienced sudden bursts of pain; in 91% of them the pain was relieved. 71% reported no complaints after cholecystectomy, 26% still had some discomfort after the operation. Two thirds of these had experienced discomfort for several years. 22% reported new or different symptoms. After surgery our patients reported a significant reduction in symptoms like sudden pain, constant pain, nausea/vomiting and bloating. 94% were very satisfied or satisfied with the outcome; 1% regretted having undergone the procedure. INTERPRETATION: Sudden attacks of pain are likely to be relieved after cholecystectomy. Our patients also experienced a number of different types of discomfort both before and after the cholecystectomy. Similar complaints also are reported by persons without gallstones, hence it is difficult to interpret the relief or worsening of these symptoms in relation to the cholecystectomy.

[Gallbladder surgery in a district hospital--a prospective registration]. / Gallekirurgi ved et lokalsykehus--prospektiv registrering.

BACKGROUND: Health authorities and patients are expected to be more active in inquiring about the outcome of surgery for each specific hospital. Prospective registration performed in a district hospital has to go on for years until the results can be evaluated. Specific data for gallbladder surgery performed in Norwegian district hospitals have not been reported before. MATERIAL AND METHODS: All 220 cholecystectomies carried out from May 1993 to March 2001 were registered prospectively. RESULTS: Two surgeons performed 93% of the operations with an average annual operator volume of 28. The operation rate was 8.5 per 10,000 inhabitants. The need for conversion was 9%. The peri and postoperative complication rate for laparoscopic and converted operations was 11%. INTERPRETATION: Our operation rate is somewhat higher than the average in Norway. The number of annual operations in a district hospital is somewhat low, but as almost all procedures are carried out by a limited number of surgeons, operator volume is compatible with data from larger hospitals in Norway. The need for conversion and the rate and seriousness of complications peri and postoperatively does not seem to be higher in this district hospital than in county and university hospitals in Norway.

[Agenesis of the gallbladder]. / Galleblaereagenesi.

BACKGROUND: Agenesis of the gallbladder, first described in 1701, is a rare, congenital malformation with an incidence of 0.01% to 0.04%. The condition can be associated with other and multiple anomalies. The diagnosis can be a random discovery during an abdominal operation or at autopsy, or an astonishing perioperative finding in a patient presenting with symptoms compatible with gallstone disease. MATERIAL AND METHODS: We present a young man with symptoms interpreted as related to gallstones. The preoperative ultrasound was misaprehended, describing a small, shrunken gallbladder filled with stones. RESULTS: At laparoscopy we found no gallbladder, but a small accumulation of connective tissue and a cord-like structure believed to be the cystic duct. Attempts to cannulate this structure failed. Postoperative endoscopic retrograde cholangiography (ERC) showed normal intra- and extrahepatic biliary ducts, but no gallbladder or cystic duct. Five years after the laparoscopy the patient still experiences attacks of pain located to the right hypogastric area. INTERPRETATION: Though agenesis of the gallbladder is a rare condition, surgeons and radiologists should be aware of it. Uncertain ultrasound pictures should be supplied by more advanced CT or MR techniques to avoid unnecessary operations searching for an absent gallbladder.