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Laparoscopic versus conventional ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy (LapConPouch Trial)—a randomized controlled trial

  • Controlled Clinical Trial
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Abstract

Purpose

Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the standard surgical procedure for ulcerative colitis (UC) and familial adenomatous polyposis (FAP). While minimal invasive techniques have been applied increasingly, clear evidence of superiority for laparoscopic pouch procedures is not yet available. The aim of the LapConPouch Trial was to compare the effectiveness of laparoscopic (LAP) versus conventional (CON) ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy.

Methods

The trial was designed as a single-centre, pre-operatively randomized, controlled trial using a two-group parallel superiority design. Eligible for participation were patients scheduled for restorative proctocolectomy either for FAP or for UC. Patients and outcome assessors were blinded to group assignment. The primary endpoint was defined as the amount of blood loss. Statistical analyses were explorative since the trial had to be stopped prematurely.

Results

A total of 42 patients (21 LAP (50.0 %); 21 CON (50.0 %)) were randomized. The trial had to be stopped prematurely due to insufficient patient recruitment. There was no difference in the amount of blood loss between both groups: LAP 261.5 ± 195.4 ml, CON 228.1 ± 119.5 ml. Secondary endpoints differ in both groups. Laparoscopic surgery was superior regarding the length of skin incision; in contrast, the conventional approach was superior in duration of operation. There were no discrepancies in length of hospital stay, postoperative pain, bowel function, and quality of life between both approaches. The conversion rate from LAP to CON approach was 23.8 %.

Conclusion

There was no difference with respect to blood loss between the LAP and the CON group. The LAP approach is feasible for restorative proctocolectomy, and IPAA seems at least as safe as CON surgery. The most obvious advantage of the minimal invasive technique is the improved cosmesis.

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Acknowledgments

This is to acknowledge the Clinical Trials Center Heidelberg (study design: Peter Kienle; study management: Dalibor Antolovic, Peter Kienle, Hanns-Peter Knaebel, Christoph Seiler; study nurse: Martina Benter), co-investigators (surgeons: Jan Schmidt, Carsten Gutt; anaesthesiologist: Markus Weigand; psychosocial follow-up: Monika Keller), Institute for Medical Biometrics and Informatics (study design: Axel Benner; data and SAE management: Peter Kienle, Ronald Limprecht; analysis: Thomas Bruckner) as well as to the gastroenterologic outpatients (Irmgard Treiber, Martina Kadmon).

Funding

This study received no specific funding.

Conflicts of interest

None.

Author information

Authors and Affiliations

  1. Department of General, Visceral and Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Serin Schiessling, Christine Leowardi, Dalibor Antolovic, Phillip Knebel, Martina Kadmon, Markus W. Büchler, Markus K. Diener & Alexis Ulrich

  2. Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany

    Serin Schiessling, Christine Leowardi, Phillip Knebel, Thomas Bruckner & Markus K. Diener

  3. Department of Surgery, University of Mannheim, Mannheim, Germany

    Peter Kienle

  4. Institute for Medical Biometrics and Informatics, University of Heidelberg, Heidelberg, Germany

    Thomas Bruckner

  5. Department of Surgery, GRN Hospitals Rhein-Neckar, Sinsheim, Germany

    Christoph M. Seiler

Authors
  1. Serin Schiessling
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  2. Christine Leowardi
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  3. Peter Kienle
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  4. Dalibor Antolovic
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  5. Phillip Knebel
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  6. Thomas Bruckner
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  7. Martina Kadmon
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  8. Christoph M. Seiler
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  9. Markus W. Büchler
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  10. Markus K. Diener
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  11. Alexis Ulrich
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Corresponding author

Correspondence to Markus W. Büchler.

Additional information

Serin Schiessling, Christine Leowardi, Markus K. Diener and Alexis Ulrich all contributed equally.

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Schiessling, S., Leowardi, C., Kienle, P. et al. Laparoscopic versus conventional ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy (LapConPouch Trial)—a randomized controlled trial. Langenbecks Arch Surg 398, 807–816 (2013). https://doi.org/10.1007/s00423-013-1088-z

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  • DOI: https://doi.org/10.1007/s00423-013-1088-z

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