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Uncut Roux-en-Y Gastrojejunostomy for Early Gastric Cancer Patients

NCT02644148 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-08-11

No results posted yet for this study

Summary

The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy.

Conditions

Interventions

PROCEDURE

Conventional Roux-en-Y Gastrojejunostomy

Conventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients

PROCEDURE

Uncut Roux-en-Y Gastrojejunostomy

Uncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Zekuan Xu, Professor · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2019-02-28

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644148 on ClinicalTrials.gov