Endoscopic Management Of Iatrogenic Esophageal Perforation After Laparoscopic Upper Gastrointestinal Surgery

Endoscopic Management Of Iatrogenic Esophageal Perforation After Laparoscopic Upper Gastrointestinal Surgery : A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Iatrogenic Esophageal Perforation
• Intervention / Treatment: Procedure: endoscopic repair of iatrogenic esophageal perforation

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharquia
    • Zagazig, Sharquia, Egypt, 1185
      • Zagazig University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: 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
No Intervention: group (2) surgical group; surgical repair of perforation after adequate drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of leak after the intervention	incidence of leak after the intervention	within one week after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of side effects of endoscopy	incidence of side effects of endoscopy	within one month after the surgery

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Said Mohamed Negm, MD, Zagazig University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: stent, endoscopy , esophagus , iatrogenic injury
• Additional Relevant MeSH Terms: Digestive System Diseases; Wounds and Injuries; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Perforation
• Other Study ID Numbers: esophageal injury

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No