Early benefits of stomach reconstruction from small intestine after surgical removal of stomach in those who have stomach cancer.

Early benefits of jejunal pouch reconstruction after total gastrectomy for gastric adenocarcinoma.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003403

Enrollment

Registered

2013-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Gastric adenocarcinoma

Interventions

Intervention1: Hunt Lawrence Jejunal pouch after total gastrectomy, esophagojejunostomy and Roux en Y: To analyze benefits of Jejunal pouch after total gastrectomy Control Intervention1: Total gastrec

Eligibility

Inclusion criteria

Inclusion criteria: •Patients with histologically confirmed gastric adenocarcinoma •Who undergo total gastrectomy with macroscopic clearance i.e. RO/ R1 resection

Exclusion criteria

Exclusion criteria: •Metastatic disease •Renal failure, chronic liver disease, inflammatory bowel disease, previous bowel resection or any other condition that might affect nutritional status of the patient apart from the malignancy or surgery

Design outcomes

Primary

Measure	Time frame
Safety â?? Morbidity associated with surgery Efficacy â?? To incidence of dumping Timepoint: Safety â?? Morbidity associated with surgery â?? prolonged intensive care, complications associated with surgery i.e. respiratory infections, anastomotic leak, bleed etc Efficacy â?? To incidence of dumping i.Early dumping: Patients who complain of crampy abdominal pain, bloating, diarrhea, giddiness within 30-60min post prandialy. ii.Late dumping: Patients who complain of giddiness, sweating within 1-3 hours post prandialy.	—

Measure

Time frame

Safety â?? Morbidity associated with surgery Efficacy â?? To incidence of dumping Timepoint: Safety â?? Morbidity associated with surgery â?? prolonged intensive care, complications associated with surgery i.e. respiratory infections, anastomotic leak, bleed etc Efficacy â?? To incidence of dumping i.Early dumping: Patients who complain of crampy abdominal pain, bloating, diarrhea, giddiness within 30-60min post prandialy. ii.Late dumping: Patients who complain of giddiness, sweating within 1-3 hours post prandialy.

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Secondary

Measure	Time frame
5.To determine the nutritional benefit of pouch reconstruction a.BMI b.PNIR Timepoint: preoperativey and every 6 months after surgery till 18 months postoperaitively;Quality of lifeTimepoint: SF36 - Preoperatively and every 6 months till 18 months after surgery;To assess mortalityTimepoint: Mortality directly related to Surgery;To assess the effect of pouch reconstruction on food intake in the post operative periodTimepoint: 4.Food intake-Quantifiable food item will be chosen, e.g. â?? slices of bread or homemade unleavened bread. Post operative intake of that item of food in a single meal will be measured as a percentage of what the patient could eat preoperatively.;To determine the incidence of late post gastrectomy complications -Heart burnTimepoint: 3.Heart burn: Patients who experience burning in chest or throat, sour taste in mouth, dysphagia, chronic cough or wheezing;To study the effect of pouch reconstruction on the course of surgery a.Operative time b.Blood loss c.Technical difficulties faced by surgeonTimepoint: 1.a-Operative time:Time it takes from the point of skin incision to skin closure. 1.b-Blood loss:â?? Amount of blood loss will be taken into account during the period of surgery. This will be assessed by the anaesthetist. 1.c-Technical difficulties faced by surgeon â?? in terms of accessibility, anatomic variation, injury to adjacent viscera, adhesions, intra-operative bleeding, instrument failure, iatrogenic perforation and general ease of surgery.	—

Measure

Time frame

5.To determine the nutritional benefit of pouch reconstruction a.BMI b.PNIR Timepoint: preoperativey and every 6 months after surgery till 18 months postoperaitively;Quality of lifeTimepoint: SF36 - Preoperatively and every 6 months till 18 months after surgery;To assess mortalityTimepoint: Mortality directly related to Surgery;To assess the effect of pouch reconstruction on food intake in the post operative periodTimepoint: 4.Food intake-Quantifiable food item will be chosen, e.g. â?? slices of bread or homemade unleavened bread. Post operative intake of that item of food in a single meal will be measured as a percentage of what the patient could eat preoperatively.;To determine the incidence of late post gastrectomy complications -Heart burnTimepoint: 3.Heart burn: Patients who experience burning in chest or throat, sour taste in mouth, dysphagia, chronic cough or wheezing;To study the effect of pouch reconstruction on the course of surgery a.Operative time b.Blood loss c.Technical difficulties faced by surgeonTimepoint: 1.a-Operative time:Time it takes from the point of skin incision to skin closure. 1.b-Blood loss:â?? Amount of blood loss will be taken into account during the period of surgery. This will be assessed by the anaesthetist. 1.c-Technical difficulties faced by surgeon â?? in terms of accessibility, anatomic variation, injury to adjacent viscera, adhesions, intra-operative bleeding, instrument failure, iatrogenic perforation and general ease of surgery.

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Countries

India

Contacts

Public ContactMadhuri Sadanala

Christian Medical College, Vellore

inians@cmcvellore.ac.in9003925018

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026