COMPARISON BETWEEN LAPAROSCOPIC TRACTION (SHEHATA TECHNIQUE) AND 2-STAGE FOWLER STEPHENS ORCHIOPEXY FOR HIGH INTRABDOMINAL UNDESCENDED TESTIS. A PROSPECTIVE RANDOMIZED STUDY.
COMPARISON
2 other identifiers
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedFirst Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedFebruary 19, 2026
February 1, 2026
1.9 years
February 12, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Testicular Survival Rate and Successful Scrotal Position
2 years
Study Arms (2)
Laparoscopic Traction (Shehata Technique)
EXPERIMENTALPreliminary 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.
2-Stage Fowler Stephens Orchiopexy
EXPERIMENTALFirst 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
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.
Eligibility Criteria
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
- Ain Shams Universitylead
- Ahmed Maher Teaching Hospitalcollaborator
Study Sites (1)
Department of Pediatric Surgery, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Cairo, Cairo Governorate, 12345, Egypt
Study Officials
- STUDY CHAIR
Soliman
Pediatric Surgery department, Faculty of Medicine, Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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