Sammenligning af hæftelinjesutur ved laparoskopisk ærmegatrektomi
Sammenligning af forstærkningsmetoder til hæftelinjesutur ved laparoskopisk ærmegatrektomi
Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion
Exclusion Criteria:
-
Age < 18 or > 65
-
BMI < 35 and > 60 kg/m2
-
American Society of Anesthesiologists (ASA) score > 3
-
Concurrent surgical procedure including:
- ventral hernia repair
- cholecystectomy
- hiatal hernia repair with posterior cruroplasty
- extensive lysis of adhesions
- other procedures that mandate addition of 'trocar(s)' or 'feeding tube'
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Over-sewing
Patients under over-sewing arm are subjected to staple line reinforcement using over-sewing method |
Sleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert). |
|
Andet: Plication
Patients under over-sewing arm are subjected to staple line reinforcement using plication method |
Sleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Immediate and early post-operative complication
Tidsramme: 0-30 days
|
Staple line bleeding |
0-30 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Immediate and early post-operative complication
Tidsramme: 0-30 days
|
Staple line leak |
0-30 days
|
|
Immediate and early post-operative complication
Tidsramme: 0-30 days
|
Re-admission and re-operation |
0-30 days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 53293
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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