COMPARISON BETWEEN LAPAROSCOPIC TRACTION (SHEHATA TECHNIQUE) AND 2-STAGE FOWLER STEPHENS ORCHIOPEXY FOR HIGH INTRABDOMINAL UNDESCENDED TESTIS. A PROSPECTIVE RANDOMIZED STUDY.

COMPARISON BETWEEN LAPAROSCOPIC TRACTION (SHEHATA TECHNIQUE) AND 2-STAGE FOWLER STEPHENS ORCHIOPEXY FOR HIGH INTRABDOMINAL UNDESCENDED TESTIS. A PROSPECTIVE RANDOMIZED STUDY.

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.

Study Setting: The study will be conducted at the Department of Pediatric Surgery, Ain Shams University hospitals .

Study Period: 2 years from the approval from the Research Ethics Committee.

Study Population and CONSORT flowchart (Appendix 1)

• Inclusion Criteria:

  1. 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.

• Exclusion Criteria:

  1. Patients who underwent previous abdominal surgery (intraperitoneal surgery).
  2. Recurrent cases.
  3. Patients older than 6 months with impalpable undescended testis with confirmed palpable testis after examination under anesthesia.
  4. Patients older than 6 months with impalpable undescended testis with associated persistent Mullarian duct remnants.
  5. 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

Sample Size Using a statistical sample power software (G*Power 3.1.9.7 for Windows, PsycInfo Database Record (c) 2022 APA) for sample size calculation, setting power at 90% and an α error at 5%, an estimated sample size of 44 children with Undescended testis (22 children undergoing laparoscopic traction of undescended testis "Shehata technique" & 22 children undergoing Fowler Stephens orchiopexy) will be needed to detect a statistically significant difference between the two groups as regard overall success rate, assuming a large effect size difference (w"15) regarding Tian et al., 2023. At least 50 children with undescended testis(25 per group) will be needed. [10].

Sampling Method The patients will be assigned randomly using block randomization method with blocks of 4,6 allocation (Appendix 2). A web-based service is utilized for block generation (Sealed Envelope Ltd. 2022, Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 10 October 2023].

Ethical Considerations:

1. The study will be presented for approval from the Research Ethical Committee (REC), Faculty of Medicine Ain shams University
2. A detailed informed consent form (Appendix 3) will be discussed with the guardians highlighting the aim of the study, the merits of the procedure and expected complication nature & rate as well as the plan of follow up.

Study Tools /Study Procedures/Study Interventions :

Laparoscopy will be used for either traction of the undescended testis or performing of Fowler- Stephens technique in a staged fashion.

1. History taking The assessment of a child with undescended testis should begin with a history, considering risk factors such as prematurity and low birth weight and any co-morbidities.

2. Examination:

   Local examination:

   After exhausting every effort to palpate the involved testis, the child is declared as having an impalpable undescended testis and booked for examination under anesthesia and proceed.

3. Preoperative preparation:

   Routine preoperative investigation will be done.

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.

A: Two Stage Fowler-Stephen Technique

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 testis is taken down on the leash of newly acquired collateral blood supply by inserting a 10 mm trocar through ipsilateral scrotum and the orchidopexy is completed.

B: Shehata Traction technique:

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.

During the first stage of either technique, the testis will be brought close to the anterior abdominal wall to enable a dedicated radiologist to perform an intraoperative ultrasound examination of the testis recording its dimensions as a baseline for further postoperative assessment.

5. Follow up:

Early postoperative care:

Patients are operated on day-case basis and will be discharged on appropriate analgesics and instructions for follow up in the clinic/Radiology Department and booked for the second stage. Long term follow up:

Patients will be followed up by clinical examination conducted by an independent examiner and an Ultrasound study with Duplex verification of vascularity 3 months after discharge following the 2nd stage marking the end-point of the study.

Both the independent examiner and the radiologist will be blinded regarding technique used in each patient.

Success definition:

It defined by:

1. Clinically palpable testis (non-atrophic), and
2. Appropriate size compared to the initial intra-operative ultrasound examination of the testis (no more than 30% volume loss).
3. Good vascularity proved by a Color Doppler 3 months after surgery.
4. Testis residing in the bottom or middle of the scrotum (scrotal neck or inguinal testis are considered an ascent/failure).

Expected complications (Literature generated) :

1. Atrophy/ smaller size(as a result of ischemic injury during dissection/clipping of the vessels).
2. Ascending testis. (eligible for redo and inclusion as per intention-to treat principle)
3. Slipped traction. (eligible for redo and inclusion as per intention-to treat principle)
4. Severely Impaired vascularity (detected by Doppler)
5. Intestinal adhesions or internal herniation.
6. Injury to Vas Deferens.
7. Epididymo-orchitis.
8. Wound infection.
9. Bleeding and hematoma.

Inclusion Criteria:

- 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.

Exclusion Criteria:

1. Patients who underwent previous abdominal surgery (intraperitoneal surgery).
2. Recurrent cases.
3. Patients older than 6 months with impalpable undescended testis with confirmed palpable testis after examination under anesthesia.
4. Patients older than 6 months with impalpable undescended testis with associated persistent Mullarian duct remnants.
5. 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