Clinical trial NCT05781022: Endoscopic Management Of Iatrogenic Esophageal Perforation After Laparoscopic Upper Gastrointestinal Surgery
Official title: Endoscopic Management Of Iatrogenic Esophageal Perforation After Laparoscopic Upper Gastrointestinal Surgery : A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iatrogenic Esophageal Perforation
Keywords: stent, endoscopy , esophagus , iatrogenic injury
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-03-23
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: incidence of leak after the intervention
timeFrame: within one week after the procedure
Secondary outcomes:
measure: incidence of side effects of endoscopy
timeFrame: within one month after the surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Sharquia
Study officials:
affiliation: ZAGAZIG UNIVERSITY HOSPITALS
name: Said Mohamed Negm, MD
role: PRINCIPAL_INVESTIGATOR
References: