Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063218) titled 'A study comparing transumbilical and supraumbilical incisions for camera-port placement in laparoscopic inguinal hernia repair' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Southern Tohoku General Hospital
Condition:
Condition - Inguinal hernia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to compare the clinical utility of transumbilical and supraumbilical incisions for camera-port placement in transabdominal preperitoneal repair (TAPP) and to contribute to establishing the optimal surgical technique.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Transumbilical incision group: During laparoscopic inguinal hernia repair using the transabdominal preperitoneal approach, a skin incision is made within the umbilical depression, and a 10-mm camera port is inserted into the abdominal cavity using an open technique.
Interventions/Control_2 - Supraumbilical incision group: During laparoscopic inguinal hernia repair using the transabdominal preperitoneal approach, a transverse skin incision is made above the umbilical depression, and a 10-mm camera port is inserted into the abdominal cavity using an open technique.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 20 years or older.
2. Patients diagnosed with inguinal hernia based on clinical findings or imaging examinations.
3. Patients considered eligible for laparoscopic inguinal hernia repair using the transabdominal preperitoneal approach.
4. Patients who provide written informed consent before enrollment in the study.
Key exclusion criteria - 1. Patients with confirmed or strongly suspected infection at the planned incision site or within the abdominal cavity.
2. Patients with recurrent inguinal hernia.
3. Patients with bilateral inguinal hernia.
4. Patients requiring emergency surgery because of incarceration, perforation, or other conditions.
5. Patients with a previous laparotomy scar at or around the umbilicus.
6. Patients with concomitant umbilical hernia.
7. Patients with renal dysfunction requiring dialysis.
8. Patients who are pregnant or may be pregnant.
9. Patients considered unsuitable for participation in this study by the attending physician.
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 14 Day
Date of IRB - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 10 Month 15 Day
Last follow-up date - 2029 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071972
Disclaimer: Curated by HT Syndication.