Totally laparoscopic versus conventional ileoanal pouch procedure--design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative pr

Abstract:

BACKGROUND:Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study. METHODS/DESIGN:This is a two armed, single centre, expertise based, preoperatively randomized, patient blinded study. It is designed as a two-group parallel superiority study. Power calculation revealed 80 patients per group in order to recruit the 65 patients to be analysed for the primary endpoint. The primary objective is to investigate intra-operative blood loss and the need for blood transfusions. We hypothesise that intra-operative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group. Additionally a set of surgical and non-surgical parameters related to the operation will be analysed as secondary objectives. These will include operative time, complications, postoperative pain, lung function, postoperative length of hospital stay, a cosmetic score and pre-and postoperative quality of life. DISCUSSION:The trial will answer the question whether there is indeed an advantage in the laparoscopic group in regard to blood loss and the need for blood transfusions. Moreover, it will generate data on the safety and potential advantages and disadvantages of the minimally invasive approach.

journal_name

BMC Surg

journal_title

BMC surgery

authors

Antolovic D,Kienle P,Knaebel HP,Schmidt J,Gutt CN,Weitz J,Koch M,Büchler MW,Seiler CM

doi

10.1186/1471-2482-6-13

subject

Has Abstract

pub_date

2006-11-24 00:00:00

pages

13

issn

1471-2482

pii

1471-2482-6-13

journal_volume

6

pub_type

杂志文章
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    更新日期:2018-08-02 00:00:00

  • En-bloc resection of thoracic calcified meningioma with inner dural layer in recapping T-saw laminoplasty: a case report.

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  • Perforated carcinoma of the caecum presenting as necrotising fasciitis of the abdominal wall, the key to early diagnosis and management.

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    更新日期:2008-01-25 00:00:00

  • Low psoas muscle index is a poor prognostic factor for lower gastrointestinal perforation: a single-center retrospective cohort study.

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    pub_type: 杂志文章

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    更新日期:2019-11-28 00:00:00

  • VFMSS findings in elderly dysphagic patients: our experience.

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    pub_type: 杂志文章

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    authors: Reginelli A,Iacobellis F,Del Vecchio L,Monaco L,Berritto D,Di Grezia G,Genovese E,Giganti M,Cappabianca S

    更新日期:2013-01-01 00:00:00

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    pub_type: 杂志文章,评审

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    pub_type: 杂志文章

    doi:10.1186/s12893-019-0517-5

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  • Esophagogastric polyurethane bezoar complicated by stomach wall microperforation and acute peritonitis: case report.

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    pub_type: 杂志文章

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    更新日期:2020-11-12 00:00:00

  • Experience with a new prosthetic anal sphincter in three coloproctological centres.

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    pub_type: 杂志文章,多中心研究

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    更新日期:2013-10-08 00:00:00

  • An outcome prediction model for exsanguinating patients with blunt abdominal trauma after damage control laparotomy: a retrospective study.

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    doi:10.1186/s12893-017-0328-5

    authors: Li FD,Kang R,Nie H,Wang XM,Zheng YH

    更新日期:2017-12-15 00:00:00

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    authors: Lu M,Wang J,Tang F,Min L,Zhou Y,Zhang W,Tu C

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  • Atherosclerosis of the right posterior hepatic artery in a patient with hilar cholangiocarcinoma undergoing left trisectionectomy: a case report of a therapeutic pitfall.

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    doi:10.1186/s12893-018-0415-2

    authors: Goto Y,Kojima S,Nomura Y,Muroya D,Arai S,Sakai H,Kawahara R,Hisaka T,Akagi Y,Tanaka H,Okuda K

    更新日期:2018-09-24 00:00:00

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    authors: Pratap A,Tiwari A,Kumar A,Adhikary S,Singh SN,Paudel BH,Bartaula R,Mishra B

    更新日期:2007-09-24 00:00:00