Endoscopic Management Of Iatrogenic Esophageal Perforation After Laparoscopic Upper Gastrointestinal Surgery

NCT ID: NCT05781022

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-08-01

Brief Summary

The investigators included all patients who were presented to General Surgery Department with Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery at Zagazig University hospital between (December 2020 to August 2023).The sample size was calculated by using open Epi program depending on the following data ; confidence interval 95% , power of the test 80% , ratio of unexposed/ exposed 1 , the success rate of surgical repair versus endoscopic repair was 98 % versus 75% respectively. Odd ratio 16 , and risk ratio 1.3 , so the calculated sample size equal 84 patients divided into two equal groups. Included patients were randomized at a 1:1 ratio to "Endoscopic Group, EG" or "Surgical Group , SG" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample). Patients will be divided into 2 groups in accordance type of preoperative

Therapy :

Group 1: "Endoscopic Group, EG" included 42 patients. Group 2: "Surgical Group , SG" included 42 patients.

Detailed Description

A- Site of the study: The investigators included all patients who were presented to General Surgery Department with Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery at Zagazig University hospital between (December 2020 to August 2023).

B- Sample size:

The sample size was calculated by using open Epi program depending on the following data ; confidence interval 95% , power of the test 80% , ratio of unexposed/ exposed 1 , the success rate of surgical repair versus endoscopic repair was 98 % versus 75% respectively. Odd ratio 16 , and risk ratio 1.3 , so the calculated sample size equal 84 patients divided into two equal groups.

c- Sample selection: Included patients were randomized at a 1:1 ratio to "Endoscopic Group, EG" or "Surgical Group , SG" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample).

D- Subjects: Patients will be divided into 2 groups in accordance type of preoperative

Therapy :

Group 1: "Endoscopic Group, EG" included 42 patients. Group 2: "Surgical Group , SG" included 42 patients.

Inclusion criteria:

Patients with Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery , failued conservative meaures .patient with good general condition (ASA I&II).

Exclusion criteria:

We excluded patients who bad general condition (ASAIII&IV&V), , respond to conservative measures.

E- Data collection (tools): All patients will subjected to the followings:

patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed radio-logically by abdominal &chest x- ray , abdominal ultrasound, pelvic and abdominal CT, upper GI endoscopy.

Study design (operational study):

A. Type of the study : A randomized Controlled Trial.

B. Steps of performance:

1. Complete history taking.

2. Clinical and laboratory results.

3. Radiological results.

4. Endoscopic management of Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery .

5. Analysis of the results.

6. Preparing conclusion and recommendation.

C-Study techniques (procedure):

For patients in EG, we began with assessment of the site & size of perforation . In this study, In this study, we used a fully covered stent (Mega stent, Taewoong Medical Industries, Gyeonggi-do, South Korea) ultra large and long (length: 24 cm, diameter: 36 mm) stent. We did not experience any complication with Mega stent, particularly migration, thanks to the design of Mega stent that fits well for the post-sleeve anatomy with reduction of migration.

Concurrently, the interventional radiology team subcutaneously drained the intraperitoneal free fluid using 2 intra-peritoneal tubes that were placed under US guidance in the sub-hepatic region and in the pelvis.

D-Outcomes:

Primary and secondary outcomes were incidence of postoperative hospital stay and complications in each group during the 3-months follow-up period, respectively.

Conditions

Iatrogenic Esophageal Perforation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group (1) endoscopic group

For patients in EG, we began with assessment of the site & size of perforation . In this study, In this study, we used a fully covered stent (Mega stent, Taewoong Medical Industries, Gyeonggi-do, South Korea) ultra large and long (length: 24 cm, diameter: 36 mm) stent. We did not experience any complication with Mega stent, particularly migration, thanks to the design of Mega stent that fits well for the post-sleeve anatomy with reduction of migration.

Concurrently, the interventional radiology team subcutaneously drained the intraperitoneal free fluid using 2 intra-peritoneal tubes that were placed under US guidance in the sub-hepatic region and in the pelvis

Group Type: ACTIVE_COMPARATOR

endoscopic repair of iatrogenic esophageal perforation

Intervention Type: PROCEDURE

For patients in EG, we began with assessment of the site & size of perforation . In this study, In this study, we used a fully covered stent (Mega stent, Taewoong Medical Industries, Gyeonggi-do, South Korea) ultra large and long (length: 24 cm, diameter: 36 mm) stent. We did not experience any complication with Mega stent, particularly migration, thanks to the design of Mega stent that fits well for the post-sleeve anatomy with reduction of migration.

Concurrently, the interventional radiology team subcutaneously drained the intraperitoneal free fluid using 2 intra-peritoneal tubes that were placed under US guidance in the sub-hepatic region and in the pelvis

group (2) surgical group

surgical repair of perforation after adequate drainage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

endoscopic repair of iatrogenic esophageal perforation

For patients in EG, we began with assessment of the site & size of perforation . In this study, In this study, we used a fully covered stent (Mega stent, Taewoong Medical Industries, Gyeonggi-do, South Korea) ultra large and long (length: 24 cm, diameter: 36 mm) stent. We did not experience any complication with Mega stent, particularly migration, thanks to the design of Mega stent that fits well for the post-sleeve anatomy with reduction of migration.

Concurrently, the interventional radiology team subcutaneously drained the intraperitoneal free fluid using 2 intra-peritoneal tubes that were placed under US guidance in the sub-hepatic region and in the pelvis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with Iatrogenic Esophageal Perforation after Laparoscopic Upper Gastrointestinal Surgery
• failued conservative meaures .
• patient with good general condition (ASA I&II). -

Exclusion Criteria

• We excluded patients who bad general condition (ASAIII&IV&V),
• respond to conservative measures.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Said Mohamed Said Abdou Negm

lecturer of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Said Mohamed Negm, MD

Role: PRINCIPAL_INVESTIGATOR

ZAGAZIG UNIVERSITY HOSPITALS

Locations

Zagazig University Hospitals

Zagazig, Sharquia, Egypt

Countries

Egypt

Other Identifiers

esophageal injury

Identifier Type: -

Identifier Source: org_study_id