Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNanchong Central Hospital
About this trial
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 85 years.
Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy.
ECOG performance status of 0 or 1.
ASA (American Society of Anesthesiologists) classification of I-III.
Disqualifiers
Evidence of potential distant metastasis found preoperatively.
History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy.
Significant contraindications for surgery (e.g., severe liver or kidney dysfunction).
Participation in any other clinical trial within the last 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Stapler Reinforcement Patch
DeviceParticipants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.
Standard Stapler
DeviceParticipants in this group will receive gastrojejunostomy with the use of Standard Stapler
Treatment groups
382 Participants
are divided into 2 treatment groupsGroup A: Stapler Reinforcement Patch GroupExperimental treatment 1 intervention
Group B: Standard Stapler GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Anastomotic Leakage
The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy.
Time frame
30 days post-surgerySecondary outcomes
1
Rate of Anastomotic Stricture
The incidence of anastomotic stricture within 3 months post-surgery. Anastomotic stricture is defined as difficulty in food passage or narrowing confirmed by imaging or endoscopy.
Time frame
3 months post-surgery2
Postoperative Bleeding Rate
The incidence of postoperative bleeding within 30 days post-surgery. Postoperative bleeding is defined as the occurrence of bleeding requiring intervention or causing significant hemoglobin drop.
Time frame
30 days post-surgery3
Mortality Rate
The rate of mortality within 30 days post-surgery.
Time frame
30 days post-surgery4
Readmission Rate
Readmission Rate
Time frame
3 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanchong Central Hospital
Lead sponsor
Guang'an Central Hospital
Collaborator
Pengan County People's Hospital
Collaborator
Yilong County people's Hospital
Collaborator
Nanbu Hospital of County Chinese Medicine
Collaborator
Langzhong People's Hospital
Collaborator
Source ClinicalTrials.gov