Comparative analysis of two different kidney harvesting incisions after retroperitoneal laparoscopic nephrectomy in living donors

ISRCTN	ISRCTN13978198
DOI	https://doi.org/10.1186/ISRCTN13978198
Sponsor	First Affiliated Hospital of Henan University of Science and Technology
Funder	First Affiliated Hospital of Henan University of Science and Technology

Submission date: 26/12/2025
Registration date: 31/12/2025
Last edited: 30/12/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Dr Kaixuan Wang
Principal investigator, Scientific, Public

No. 24, Jinghua Road
Jianxi District, Luoyang, Henan
471003
China

Phone	+86 0379-64720600
Email	kaixuan3437@163.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Health services research
Scientific title	Prospective randomized trial of abdominal versus lumbar extraction incisions after retroperitoneal laparoscopic left nephrectomy in living donors
Study objectives	This study was designed to address the critical knowledge gap regarding optimal extraction incision placement in retroperitoneal laparoscopic living donor nephrectomy. We hypothesized that abdominal extraction incisions would result in lower incisional hernia rates and reduced abdominal wall dysfunction compared to lumbar incisions, while maintaining equivalent graft outcomes and operative safety. Our primary objectives were to compare incisional hernia incidence and motor function deficits between techniques, with comprehensive assessment of pain trajectories, sensory outcomes, and long-term quality of life as secondary endpoints.
Ethics approval(s)	Approved 30/05/2024, The Ethics Committee of The First Affiliated Hospital of Henan University of Science and Technology (No. 24, Jinghua Road, Jianxi District, Luoyang, Henan, 471003, China; +86 0379-64922216; N/A), ref: 2024-03-K0088
Health condition(s) or problem(s) studied	Optimal extraction incision placement in retroperitoneal laparoscopic living donor nephrectomy.
Intervention	This prospective, single-blind RCT involved living kidney donors who were randomized 1:1 to an abdominal diagonal or a lumbar horizontal extraction incision. Randomization and Blinding Participants were randomized in a 1:1 ratio to either the abdominal or lumbar extraction group using computer-generated block randomization with variable block sizes of 4, 6, and 8. Randomization was stratified by surgeon experience (junior with less than 50 prior retroperitoneal nephrectomies, or senior with 50 or more procedures) and operative side (left or right kidney). Randomization was stratified by surgeon experience (junior with less than 50 prior retroperitoneal nephrectomies, or senior with 50 or more procedures). All nephrectomies were performed on the left side; right-sided donations were excluded during screening (see Participant Selection). The allocation sequence was generated by an independent statistician and concealed using sequentially numbered, opaque, sealed envelopes that were opened in the operating room immediately before incision placement. Given the nature of the surgical intervention, surgeons and operating room personnel could not be blinded to group allocation. However, all postoperative assessments were performed by trained research nurses and physiotherapists who remained blinded to the extraction technique throughout the study period. Blinding was ensured by standardizing surgical dressings to conceal the incision location, and patients were instructed not to discuss surgical details with assessors. Surgical dressings were standardized to conceal incision location during early postoperative evaluations. The biostatistician performing the primary analysis remained blinded until database lock. Surgical Standardization All procedures were performed under general anesthesia with endotracheal intubation using a standardized anesthetic protocol that included preoperative multimodal analgesia with acetaminophen 1000 mg and celecoxib 200 mg orally. Intraoperative remifentanil infusion was titrated to maintain hemodynamic stability, with a mean total dose of 0.15 ± 0.04 mcg/kg/min (total cumulative dose per patient: 18.6 ± 4.2 mcg/kg based on median operative time of 143 minutes). Local anesthetic infiltration with 0.25% bupivacaine (total volume: 15 ± 3 mL) was performed at all port sites before incision, with equal distribution (5 mL per port site) to ensure uniform analgesic coverage of the surgical access areas. The retroperitoneal space was established using the balloon dissection technique, with the patient positioned in lateral decubitus with the operative side elevated. Three trocars were placed in standardized locations: the primary 12-mm camera port 2 cm above the iliac crest at the mid-axillary line, a 5-mm port at the anterior axillary line below the costal margin, and a 5-mm port at the posterior axillary line. Pneumoretroperitoneum was maintained at 12-14 mmHg using CO2 insufflation. The surgical dissection followed a systematic approach beginning with the identification of the psoas muscle and ureter, followed by isolation of the gonadal vessels and subsequent identification of the renal hilum. The renal artery was secured with three Hem-o-lok clips and divided, followed by similar management of the renal vein. The ureter was clipped and divided as distally as possible while maintaining adequate length for recipient implantation. Throughout the procedure, meticulous attention was paid to preserving perirenal fat and avoiding capsular trauma. For kidney extraction in the abdominal incision group, the anterior 5-mm port incision was extended diagonally toward the umbilicus to create a 5-6 cm muscle-splitting incision through the external oblique, internal oblique, and transversus abdominis muscles. The incision was oriented parallel to the dermatomal distribution to minimize nerve transection. In the lumbar incision group, the posterior 5-mm port was extended horizontally in a ventral direction, creating a 5-6 cm incision through the latissimus dorsi and underlying musculature. Standardized closure techniques were employed for both groups. The fascial layers were closed with continuous 1-0 polydioxanone sutures, ensuring adequate tissue purchase without excessive tension. Subcutaneous tissues were approximated with interrupted 2-0 polyglactin sutures, and skin closure was achieved with 3-0 poliglecaprone subcuticular sutures. No prophylactic mesh reinforcement was used in either group. A closed-suction drain was placed through the camera port site and removed when output was less than 30 mL per 24 hours. Postoperative Management Protocol Postoperative analgesia followed a standardized multimodal protocol designed to minimize opioid exposure while ensuring adequate pain control. The regimen included scheduled acetaminophen 1000 mg every 6 hours, ketorolac 30 mg every 8 hours for 48 hours (with renal function monitoring), and patient-controlled analgesia with morphine (1 mg bolus, 8-minute lockout, no basal rate) for breakthrough pain. Transition to oral analgesics occurred when patients tolerated oral intake, typically within 24 hours. Early mobilization was encouraged with patients ambulating within 6 hours postoperatively when hemodynamically stable. Progressive activity advancement followed a structured protocol with specific daily goals. Dietary advancement proceeded from clear liquids to regular diet as tolerated, with antiemetic prophylaxis using ondansetron and dexamethasone. Thromboprophylaxis consisted of sequential compression devices and early ambulation, with pharmacologic prophylaxis reserved for high-risk patients.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Incisional hernia development measured using ultrasound examination at 12 months after the operation
Key secondary outcome measure(s)	Total opioid consumption within the first 72 hours, calculated as morphine milligram equivalents measured using data collected from patient medical records at one time point Surgical and Safety Outcomes, assessed through mean operative time measured using data collected from patient medical records at one time point
Completion date	30/09/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	387
Total final enrolment	240
Key inclusion criteria	1. Aged between 18 and 65 years 2. Body mass index (BMI) between 18.5 and 29.9 kg/m². The BMI upper limit of 29.9 kg/m² was selected to minimize confounding from obesity-related complications such as hernia and wound healing issues, while maintaining generalizability. 3. Estimated glomerular filtration rate greater than 80 mL/min/1.73m² 4. American Society of Anesthesiologists (ASA) physical status classification I or II
Key exclusion criteria	1. Previous major abdominal or retroperitoneal surgery 2. Known abdominal wall hernia or significant diastasis recti, chronic pain syndromes requiring regular analgesic use 3. Neuromuscular disorders affecting abdominal wall function 4. Active psychiatric conditions that could impact pain perception or reporting 5. Pregnancy or plans for pregnancy within the study period 6. Any contraindication to retroperitoneal laparoscopic surgery 7. Donors with variant renal anatomy requiring extensive dissection or those requiring right-sided nephrectomy were excluded to maintain procedural homogeneity 8. Right-sided nephrectomies were excluded to maintain procedural homogeneity and minimize anatomical variability, as the right kidney presents distinct surgical challenges
Date of first enrolment	01/03/2023
Date of final enrolment	30/09/2023

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

29/12/2025: Study’s existence confirmed by the Medical Ethics Committee of the First Affiliated Hospital of Henan University of Science and Technology, China.