Compression pre-stapler firing and post-ignition wait during sleeve gastrectomy: a prospective randomized trial

Sermet, Medeni

doi:10.1590/1516-3180.2023.0163.140823

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Sao Paulo Medical Journal

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Original Article • Sao Paulo Med. J. 142 (3) • 2024 • https://doi.org/10.1590/1516-3180.2023.0163.140823 copy

Compression pre-stapler firing and post-ignition wait during sleeve gastrectomy: a prospective randomized trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

BACKGROUND:

Insufficient research exists on the stapling technique in and duration of laparoscopic sleeve gastrectomy (LSG).

OBJECTIVES:

This study aimed to assess the clinical outcomes using a 30-second precompression and post-firing waiting time without extra support for the stapling line.

DESIGN AND SETTINGS:

Randomized controlled prospective study at a university hospital.

METHODS:

This study included 120 patients treated between January 2022 and February 2023. The patients were divided into the non-waiting group (T0) and waiting group (T1), each with 60 patients. Perioperative complications were analyzed using statistical tests.

RESULTS:

The waiting group (T1) showed a significant reduction in the number of intraoperative bleeding points requiring intervention compared with the non-waiting group (T0) (81 versus 134, P < 0.05). In T0, postoperative C-reactive protein (CRP) levels increased (P < 0.05) and hemoglobin levels decreased significantly (P <0.05). The study recorded 22 postoperative complications, accounting for 18.3% of all cases during the 30-day postoperative period.

CONCLUSIONS:

The study concluded that the 30 sec + 30 sec stapling technique reduces perioperative bleeding, length of stay, and serious complication rates and is practical and effective for LSG.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov with registration code NCT05703035; link: https://clinicaltrials.gov/ct2/show/NCT05703035.

KEY WORDS (MeSH terms):
Gastrectomy; Stapling; Hemorrhage

AUTHOR KEY WORDS:
Surgical stapling; Bariatrics; Surgical staple; Morbid obesities; Bariatric surgery

Parameters		T0 (n = 60)	T1 (n = 60)	P
Gender (Female/Male)		48/12 (80.0%/20.0%)	50/10 (83.3%/16.7%)	0.498^ Chi-square test;
Age (years)		33.8 (20-59)	34.3(21-56)	0.439^* * Student's t-test (mean, standard deviation);
Height (cm)		159 (148–179)	158 (157–182)	0.632^* ***** Mann–Whitney test; P < 0.05, considered statistically significant;.
Weight (kg)		117.2 (105-165)	116.4(107-159)	0.454^* ***** Mann–Whitney test; P < 0.05, considered statistically significant;.
BMI (kg/cm²)		42.3 (40.1–49.2)	43.1(40.5, 2–48.9)	0.543^* ***** Mann–Whitney test; P < 0.05, considered statistically significant;.
Obesity-related comorbidity
	T2D	22 (36.7%)	20 (32.7%)	0.434^* ***** Mann–Whitney test; P < 0.05, considered statistically significant;.
	Hypertension	11 (30.0%)	10 (16.3%)	0.657^* ***** Mann–Whitney test; P < 0.05, considered statistically significant;.
	OSAS	5 (8.3%)	6 (9.8%)	0.322^* ***** Mann–Whitney test; P < 0.05, considered statistically significant;.
	Hyperlipidemia	14 (23.3%)	15 (24.5%)	0.645^* ***** Mann–Whitney test; P < 0.05, considered statistically significant;.

Parameters		T0 (n = 60)	T1 (n = 60)	P
İntraoperative
Operation time(minutes)		52.4 (7.8)^* * Student's t-test (mean, standard deviation);	64.1 (5.3)	< 0,001^ Mann–Whitney test;
Number of staples used		5.12 (4-6)	5.26 (4-6)	0,452^ Mann–Whitney test;
Number of bleeding points		134 (0-5)	81 (0-3)^* * Student's t-test (mean, standard deviation);	0,003^ Mann–Whitney test;
Intraoperative blood loss (mL)		30 (15–25)	15 (10–25)^* * Student's t-test (mean, standard deviation);	0,001^* * Student's t-test (mean, standard deviation);
Clip for hemostasis (median)		3 (0–5)	2 (0–4)	0,116^ Mann–Whitney test;
Number of patients without bleeding %		11	17	0,002^ Mann–Whitney test;
Postoperative
Drain Mean blood loss (ml)		119.4 (30-400)	114.6 (30-225)	0,301^* * Student's t-test (mean, standard deviation);
Clavien-Dindo Classification
	Transfusion %	2 (3.3)	0^* * Student's t-test (mean, standard deviation);	0,042^* * Student's t-test (mean, standard deviation);
	Post Op bleeding %	12 (20)	5 (8.3)^* * Student's t-test (mean, standard deviation);	< 0,001^* * Student's t-test (mean, standard deviation);
	Postop leak	0	0	1,00^* * Student's t-test (mean, standard deviation);
	Thromboembolic event	0	0	1,00^* * Student's t-test (mean, standard deviation);
	Hematoma %	1(1.7)	0	0,754^* * Student's t-test (mean, standard deviation);
	Vomiting %	1 (1.7)	2 (3.3)	0,342^* * Student's t-test (mean, standard deviation);
	Fever %	0	1	0,754^* * Student's t-test (mean, standard deviation);
Length of stay (days)		2.35 (2-5)	2.14 (2-3)^* * Student's t-test (mean, standard deviation);	0,02^* * Student's t-test (mean, standard deviation);
Gastric tissue thickness (mm)		0.27 (0.3)	0.27 (0.2)	0,978^* * Student's t-test (mean, standard deviation);

Parameters		T0 (n = 60)	T1 (n = 60)	P
Preoperative
	WBC (10^3 /uL)	7.7 (2.2)	7.2 (3.5)	0,345^* * Student's t-test (mean, standard deviation);
	Hemoglobin (g/dL)	13.2 (3.2)	13.4 (3.1)	0,467^* * Student's t-test (mean, standard deviation);
	PLT (10^3 /uL)	231 (114)	234 (98)	0,629^ Mann–Whitney test;
	CRP (mg/L)	2.0 (1.8)	2.1 (0.7)	0.784^* * Student's t-test (mean, standard deviation);
	INR	0,98 (0,1)	0.98 (0,1)	0,493^ Mann–Whitney test;
	PT (sn)	14.0 (0.2)	14.1 (0.3)	0,618^ Mann–Whitney test;
	PTT (sn)	83.2 (8.2)	82.9 (7.0)	0,382^ Mann–Whitney test;
	Fibrinogen (mg/dL)	270 (78)	274 (72)	0,234^ Mann–Whitney test;
	USG	N	N	1.00^ Mann–Whitney test;
Postoperative
	WBC (10^3 /uL)	13.7 (4.9)	12.9 (6.2)	0,237^* * Student's t-test (mean, standard deviation);
	Hemoglobin (g/dL)	11.2 (0.6)^* * Student's t-test (mean, standard deviation);	11.9 (1.1)	0,025^* * Student's t-test (mean, standard deviation);
	PLT (10^3 /uL)	244 (102)	239 (98)	0,532^ Mann–Whitney test;
	CRP (mg/L)	28.46 (8.5-110.6)	21.3 (7.3-87.6)^* * Student's t-test (mean, standard deviation);	0.014^* * Student's t-test (mean, standard deviation);
	INR	0.99 (0.05)	1.0 (0.03)	0.493^ Mann–Whitney test;
	PT (sn)	14.2 (0.2)	14.4 (0.3)	0.578^ Mann–Whitney test;
	PTT (sn)	84.2 (7.0)	83.9 (7.3)	0.382^ Mann–Whitney test;
	Fibrinogen (mg/dL)	274 (72)	277 (74)	0.234^ Mann–Whitney test;
	USG	1 (hematoma)	N	1.00^* * Student's t-test (mean, standard deviation);

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[1] Address for correspondence: Medeni Sermet Departments of General Surgery, Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Medeniyet University Dr. Erkin Street, 3, Kadıköy, 34732, Istanbul, Turkey Phone: +905072367020 E- mail: sermetmedeni@gmail.com