NCT07421310

Brief Summary

The goal of this clinical trial is to compare between laparoscopic traction (Shehata technique) with 2-Stage Fowler Stephens orchiopexy in cases of high intra-abdominal undescended testis in a prospective randomized manner to verify the results of the Shehata technique against the reference standard Fowler-Stephens Orchiopexy in fullfilling the objective of placing a high intra-abdominal testis into the ipsilateral scrotal compartment without the occurance of later atrophy or ascent on follow up. Type of Study: Prospective randomized clinical study that conforms to the CONSORT statement guidelines \[9\]. Patients will be divided into 2 groups randomized by block randomization method with an intention-to treat approach into: Group 1: Patients will undergo the Shehata Traction technique. Group 2: Patients will undergo Folwer-Stephens technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

Laparoscopic Traction (Shehata Technique), 2-Stage Fowler Stephens Orchiopexy, High Intrabdominal Undescended Testis

Outcome Measures

Primary Outcomes (1)

  • Testicular Survival Rate and Successful Scrotal Position

    2 years

Study Arms (2)

Laparoscopic Traction (Shehata Technique)

EXPERIMENTAL

Preliminary traction to lengthen the testicular vessels by applying a 3/0 Ethibond suture to the testis fixing it to abdominal wall near the contralateral Anterior Superior Iliac Spine. The second stage will be planned after 2 weeks similar in principle to the 2nd stage Fowler - Stephens orchiopexy.

Procedure: Laparoscopic Traction (Shehata Technique) And 2-Stage Fowler Stephens Orchiopexy

2-Stage Fowler Stephens Orchiopexy

EXPERIMENTAL

First Stage of Stephen Fowler Technique A 5 mm incision and port is placed in the left mid- epigastrium through with a 5 mm gasper forceps is introduced into the abdominal cavity. A 5 mm instrument is then placed in the right abdomen below the horizontal plane of umbilicus. Through this port a 5 mm endoclip applicator can be passed. The peritoneum overlying the testicular vessels 2 cm cephalad to the testis is incised .The testicular vessels are then clipped or cauterized and divided. When one is planning to perform orchidopexy in two stages, no dissection should be carried out in the vicinity of the testis in the first stage. The triangular leash of the peritoneum between the vas and vessels should not be dissected as it is here that a collateral circulation develops from the artery to the vas deferens and the peritoneal vessels. Second Stage of Stephen Fowler Technique In the second stage Stephen-Fowler procedure, again three ports are placed similar to the first stage. Now the

Procedure: Laparoscopic Traction (Shehata Technique) And 2-Stage Fowler Stephens Orchiopexy

Interventions

4\. Operative details: Commenced with examination under general anesthesia. If testis is impalpable at the inguinal region, a diagnostic laparoscopy follows: 1. If the diagnostic laparoscopy reveals vanishing testis, the patient will be excluded from the study. 2. If diagnostic laparoscopy reveals intrabdominal test is which can be brought to scrotum in one stage (as evidenced by ability of the testis to reach the contralateral internal ring with no/mild tension) the patient will be excluded from the study. 3. Otherwise, a staged procedure traction technique or Fowler Stephens technique as per block allocation will be performed and this patient will be included in the study.

2-Stage Fowler Stephens OrchiopexyLaparoscopic Traction (Shehata Technique)

Eligibility Criteria

Age6 Months - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Patients older than 6 months with impalpable undescended testis confirmed to be high intrabdominal testis after examination under anesthesia and laparoscopic exploration finding a testis that cannot be brought to scrotum in one stage as evidenced by failure to reach the contralateral internal inguinal ring.

You may not qualify if:

  • Patients who underwent previous abdominal surgery (intraperitoneal surgery).
  • Recurrent cases.
  • Patients older than 6 months with impalpable undescended testis with confirmed palpable testis after examination under anesthesia.
  • Patients older than 6 months with impalpable undescended testis with associated persistent Mullarian duct remnants.
  • Patients older than 6 months with impalpable undescended testis with confirmed intrabdominal testis which can be brought to scrotum in one stage after laparoscopic exploration. (Tensionless reach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Surgery, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Cairo, Cairo Governorate, 12345, Egypt

Location

Study Officials

  • Soliman

    Pediatric Surgery department, Faculty of Medicine, Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1: Patients will undergo the Shehata Traction technique. Group 2: Patients will undergo Folwer-Stephens technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

January 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations