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Postcholecystectomy Syndrome clinical trials

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NCT ID: NCT06405906 Recruiting - Dietary Habits Clinical Trials

A Randomized Controlled Trial Comparing Fat-free Versus Balanced (WHO) Diet in Gallstone Disease

RADIGAL
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

The goal of this trial is to assess the effect on the quality of life (QoL) of recommending a fat-free diet versus a balanced WHO diet in symptomatic patients with gallstones and in patients undergoing cholecystectomy for gallstone disease. The main question it aims to answer is: • Is balanced WHO diet as good as low-fat diet in terms of patient reported outcomes when gallstone disease is managed non-operatively (RADIGAL-1) or cholecystectomy is performed (RADIGAL-2)? A validated QoL questionnaire (Gastrointestinal Quality of Life Index - GIQLI) will be administered both at baseline and during follow-up. Analysis of covariance with ordinary least squares estimation will be applied to estimate between-group differences in GIQLI scores at 3 months (primary endpoint). Patient adherence and the disease-related symptoms occurrence or hospitalizations will also be appraised (secondary endpoint). Participants presenting with biliary colic or acute cholecystitis (RADIGAL-1) or undergoing cholecystectomy for gallstones (RADIGAL-2) will: - be randomly assigned to recommending either a fat-free or a balanced WHO diet . - be contacted via phone call to complete the GIQLI questionnaire and document overall adherence to the diets and secondary outcome events. This trial examines the impact of diet on adverse events in gallstone disease, representing the first randomized study to focus on this aspect.

NCT ID: NCT05856682 Enrolling by invitation - Post Operative Pain Clinical Trials

Pre-incision Versus Lapaorscopic-assisted Transversus Abdominis Plane (TAP) and Rectus Sheath Block for Post-Cholecystectomy Pain

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare pre-incision vs laparoscopic assisted Transversus abdominis plane and rectus sheath block in patients undergoing laparoscopic cholecystectomy. The main question it aims to answer is: • if the effectiveness of TAP and rectus sheath block varies according to whether it is performed pre-incisional (pre emptive) or intraoperatively under Laparoscopic vision for laparoscopic cholecystectomies. Participants will be assessed for pain at 3,6,12, and 24 hrs after surgery. Researchers will compare pain score between Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath block vs Pre-incision TAP (PITAP ) .

NCT ID: NCT05436626 Completed - Clinical trials for Common Bile Duct Injury

Post-cholecystectomy Major Bile Duct Injury

Start date: February 1, 2014
Phase: N/A
Study type: Interventional

Bile duct injury (BDI) is one of the devastating recognized complications of cholecystectomy which does not respect the seniority or experience of the surgeon. It has a disastrous impact on long-term survival, health-related quality of life, and healthcare costs as well as high rates of litigation. The incidence of BDI increased with the introduction of laparoscopic cholecystectomy (LC) with an incidence of around 0.3-1.5%. The initial aim of BDI is to manage abdominal and biliary sepsis and to transform an acute BDI into a controlled external biliary fistula. The surgical treatment of postcholecystectomy BDI success depends on many factors as the severity of the injury, the centers and surgeon's experiences, the patient's condition, and the reconstruction time. The optimal time for the reconstruction and the patient's condition remains an active topic of interest and debate. Many papers discussed their impact on the short and long-term outcomes with different conflicting results from different institutions. Based on the previous data and the absence of guidelines that recommend the timing of BDI reconstruction, the decision for the timing of reconstruction should be based on the predicted success of the operation, costs, and patient quality of life. If comparable morbidity and mortality outcomes can be obtained, patient quality of life and effective use of healthcare resources should be taken into consideration. We hypothesized that inadequate sepsis control and BDI reconstruction can be done safely at any time of presentation. Our study aimed to present our experience in the management of major post-cholecystectomy BDI with HJ and analyze the impact of both the reconstruction time and the control of sepsis on the BDI reconstruction success rate. By analyzing the results of these three treatment strategies, we can better understand the factors that affect reconstruction success, costs, and health-related quality of life associated with BDI and subsequent repair.

NCT ID: NCT05243225 Not yet recruiting - Bile Duct Injury Clinical Trials

Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury

Start date: June 2023
Phase:
Study type: Observational [Patient Registry]

Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.

NCT ID: NCT04329143 Completed - Laparocele Clinical Trials

Post-Cholecystectomy Gall Bladder Remnant and Cystic Duct Stump Stone

Start date: January 1, 2013
Phase: N/A
Study type: Interventional

Introduction: cholecystectomy relieves pre-surgical symptoms of gallbladder disease. The persistence of symptoms was recorded in 10 - 20% of cases. Residual gall bladder/cystic duct stump stone is one of the most important cause. Aim: to compare between open and laparoscopic completion cholecystectomy of gall bladder remnant and cystic duct stump syndrome as regard short and long term outcome. Methods: This prospective study was conducted on 20 cases with residual GB/cystic duct stump stone. The diagnosis was guided by ultrasound and magnetic resonance cholangio-pancreatography. All cases were managed by using completion cholecystectomy - either open or laparoscopic. All preoperative, operative, and postoperative data were collected...

NCT ID: NCT04134546 Not yet recruiting - Biliary Fistula Clinical Trials

Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy

Start date: October 30, 2019
Phase: N/A
Study type: Interventional

Bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. It should be regarded as preventable. The advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. Population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) Bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). Although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). It has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography Recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

NCT ID: NCT03401424 Recruiting - Clinical trials for Postcholecystectomy Syndrome

Comparison of Two Kinds of Biliary Intestinal Reconstruction in Cholangiectasia

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

To observe and compare the short-term and long-term effects of different biliary and intestinal reconstruction methods for the treatment of congenital cystic dilatation of bile duct .

NCT ID: NCT02833103 Recruiting - Clinical trials for Sphincter of Oddi Dysfunction

Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

Start date: July 2016
Phase: Phase 4
Study type: Interventional

Sphincter of Oddi dysfunction (SOD) refers to biliary kinetic abnormality of the sphincter of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile duct (CBD) dilation or onset of pancreatitis. Pain caused by SOD affects the quality of life (QoL).The primary objective of this trial is to evaluate the efficacy of relieving abdominal pain of Pinaverium Bromide in medication therapy for patients with post-cholecystectomy SOD.

NCT ID: NCT02260154 Completed - Clinical trials for Post-cholecystectomy Gastrointestinal Spasms

Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm

ODYSSEY
Start date: July 2015
Phase:
Study type: Observational

Prospective, multicenter, non-comparative, observational program designed to assess the effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID) and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms

NCT ID: NCT01765465 Completed - Clinical trials for Postcholecystectomy Syndrome

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Start date: January 2013
Phase: Phase 4
Study type: Interventional

Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal. The pathogenesis of PCS has not been identified; therefore there is no consensus of medical treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients with cholesterol gallstones, and to promote biliary lipid secretion. The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS and symptoms change after laparoscopic cholecystectomy