A randomised trial comparing short-term outcomes of "Uncut" Roux-en-Y gastrojejunostomy and standard Roux-en-Y gastrojejunostomy following partial gastrectomy/palliative bypass for gastric adenocarcinoma
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- 1. Gastric emptying time by nuclear gastric emptying scan.2. Time taken to institute solid diet
Study Overview
Brief Summary
This study is a randomised control trail comparing the effects of 2 forms of reconstruction after partial gastrectomy for gastric cancer viz, uncut Roux-en-Y gastrojejunostomy and standard Roux-en-Y gastrojejunostomy. The study will be conducted at Christian Medical College, Vellore. Sixty-eight patients who fulfill the inclusion and exclusion criteria will be enrolled for the study. The primary outcome measures will be gastric emptying time on 15th postoperative day by nuclear scan and time taken to institute solid diet postoperatively. The secondary outcome measures will be overall mortality rate, overall morbidity rate, time taken to discontinue nasogastric intubation, pre- and post-operative Viscik grading, duration of post-operative hospital stay and need for reoperation.
Study Design
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing partial gastrectomy for gastric adenocarcinoma.
- •Age of the patient: 18 years and above.
Exclusion Criteria
- •Patients who have undergone prior gastric operations or vagotomy.
Outcomes
Primary Outcomes
1. Gastric emptying time by nuclear gastric emptying scan.2. Time taken to institute solid diet
Time Frame: Gastric emptying time on the 15th postoperative day
Secondary Outcomes
- 1. Mortality rate.2. Overall morbidity rate.3. Time taken to discontinue nasogastric intubation.4. Viscik grading pre- and post-operatively.5. Post-operative hospital stay.6. Any reoperation.(Immediate postoperative period during the hospital stay)